--- title: "Katy’s 340B Compass" url: https://virtue340b.com/content-hub/katys-340b-compass/ date: 2025-07-22 modified: 2026-07-24 lang: en author: "Toto SEO" description: "Katy's 340B Compass:  Navigate 340B Compliance with Confidence Join Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, as she unpacks the complexities of the 340B Program through practical insights,..." word_count: 214 --- # Katy’s 340B Compass # Katy's 340B Compass: Navigate 340B Compliance with Confidence Join Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, as she unpacks the complexities of the 340B Program through practical insights, candid discussions, and clear guidance for covered entities. ![logo-katy-compass](https://virtue340b.com/wp-content/uploads/2026/01/logo-katy-compass-scaled.png) **Got a 340B compliance question? ** Submit it below, and Katy may answer it in an upcoming vlog episode! Submit Your Question Here The 340B Program is complex - but it doesn't have to feel overwhelming. Katy's 340B Compass was created to help healthcare leaders, compliance officers, and 340B teams navigate the program with clarity and confidence. Each episode offers a fresh perspective, grounded in real-world experience and aligned with Virtue 340B's mission of integrity and transparency. **Value Highlights:** ## Explore the Compass Episodes Browse Katy's latest episodes and dive into the conversations that matter most to your program. From HRSA audit preparation to everyday compliance challenges, Katy provides actionable takeaways you can bring back to your team.   **Listen wherever you get your podcasts by clicking the icon below. or viewing the videos below.** [ ![logo-podcasts-katy-compass-03](https://virtue340b.com/wp-content/uploads/2026/01/logo-podcasts-katy-compass-03.png) ](https://podcasts.apple.com/us/podcast/katys-340b-compass-compliance-made-clear/id1866225024) [ ![logo-podcasts-katy-compass-02](https://virtue340b.com/wp-content/uploads/2026/01/logo-podcasts-katy-compass-02.png) ](https://open.spotify.com/show/4gweTuD4iZwt4JuGNvr4iu?si=e2ec50fbdc864df4&nd=1&dlsi=5242e2baef0f4614) [ ![logo-podcasts-katy-compass-01](https://virtue340b.com/wp-content/uploads/2026/01/logo-podcasts-katy-compass-01.png) ](https://www.iheart.com/podcast/269-katys-340b-compass-complia-315528161/) [ Ep 24 - Manufacturer Audits: Staying Organized and In Scope ![Manufacturer audits can be a complex part of 340B program oversight, especially when an inquiry becomes a formal audit. In this episode of Katy’s 340B Compass, Katy Lees discusses how covered entities can approach manufacturer audits with clarity, preparation, and a disciplined focus on scope. This episode covers the importance of seeking legal or consultant guidance, keeping communication organized and preferably in writing, asking clarifying questions when needed, and understanding when deadline extensions may be appropriate. Katy also explains why it is critical to stay within the approved audit scope, including the specific drugs and time period under review. This conversation is particularly relevant for health system executives, compliance leaders, pharmacy leaders, legal teams, and 340B operations teams. As Principal 340B Compliance Advisor at Virtue 340B, Katy translates a challenging audit scenario into practical oversight considerations that help organizations demonstrate program knowledge, internal coordination, and compliance safeguards. Visit Virtue 340B’s episode landing page at https://virtue340b.com/content-hub/katys-340b-compass/ to watch this episode and explore other platform options.](https://i.ytimg.com/vi/uD5Fe3ZR1xM/maxresdefault.jpg) ](https://www.youtube.com/watch?v=uD5Fe3ZR1xM) [ Subscribe](http://www.youtube.com/channel/UCvfWkvgB8yS1JELGKCvnkqw?sub_confirmation=1&feature=subscribe-embed-click) ##### Ep 24 - Manufacturer Audits: Staying Organized and In Scope October 6, 2026 1:40 pm [ ![Manufacturer audits can be a complex part of 340B program oversight, especially when an inquiry becomes a formal audit. In this episode of Katy’s 340B Compass, Katy Lees discusses how covered entities can approach manufacturer audits with clarity, preparation, and a disciplined focus on scope. This episode covers the importance of seeking legal or consultant guidance, keeping communication organized and preferably in writing, asking clarifying questions when needed, and understanding when deadline extensions may be appropriate. Katy also explains why it is critical to stay within the approved audit scope, including the specific drugs and time period under review. This conversation is particularly relevant for health system executives, compliance leaders, pharmacy leaders, legal teams, and 340B operations teams. As Principal 340B Compliance Advisor at Virtue 340B, Katy translates a challenging audit scenario into practical oversight considerations that help organizations demonstrate program knowledge, internal coordination, and compliance safeguards. Visit Virtue 340B’s episode landing page at https://virtue340b.com/content-hub/katys-340b-compass/ to watch this episode and explore other platform options.](https://virtue340b.com/wp-content/plugins/youtube-feed-pro/img/placeholder.png) Manufacturer audits can be a complex part of 340B program oversight, especially when an inquiry becomes a formal audit. In this episode of Katy’s 340B Compass, Katy Lees discusses how covered entities can approach manufacturer audits with clarity, preparation, and a disciplined focus on scope. This episode covers the importance of seeking legal or consultant guidance, keeping communication organized and preferably in writing, asking clarifying questions when needed, and understanding when deadline extensions may be appropriate. Katy also explains why it is critical to stay within the approved audit scope, including the specific drugs and time period under review. This conversation is particularly relevant for health system executives, compliance leaders, pharmacy leaders, legal teams, and 340B operations teams. As Principal 340B Compliance Advisor at Virtue 340B, Katy translates a challenging audit scenario into practical oversight considerations that help organizations demonstrate program knowledge, internal coordination, and compliance safeguards. Visit Virtue 340B’s episode landing page at https://virtue340b.com/content-hub/katys-340b-compass/ to watch this episode and explore other platform options. 1 0 Ep 24 - Manufacturer Audits: Staying Organized and In Scope ](https://www.youtube.com/watch?v=uD5Fe3ZR1xM) Ep 24 - Manufacturer Audits: Staying Organized and In Scope Katy's 340B Compass October 6, 2026 1:40 pm [ ![HRSA audit readiness doesn't begin when an audit notice arrives. It is built through daily program awareness, consistent monitoring, clear documentation, and the ability to explain how your organization manages 340B requirements in practice. In this episode of Katy’s 340B Compass, Katy Lees discusses practical ways to prepare for a HRSA audit, including knowing your program, practicing the data pull, assigning clear ownership, reviewing policies and procedures, organizing documentation, validating information before submission, protecting PHI and sensitive data, and demonstrating safeguards. This conversation is especially relevant for health system executives, compliance leaders, pharmacy leaders, 340B program managers, and teams responsible for operational oversight. Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, brings a clear and structured perspective to a complex process, helping organizations approach audit readiness with greater confidence, clarity, and control. Visit Virtue 340B’s episode landing page, https://virtue340b.com/content-hub/katys-340b-compass/, to watch this episode and explore other platform options.](https://virtue340b.com/wp-content/plugins/youtube-feed-pro/img/placeholder.png) HRSA audit readiness doesn't begin when an audit notice arrives. It is built through daily program awareness, consistent monitoring, clear documentation, and the ability to explain how your organization manages 340B requirements in practice. In this episode of Katy’s 340B Compass, Katy Lees discusses practical ways to prepare for a HRSA audit, including knowing your program, practicing the data pull, assigning clear ownership, reviewing policies and procedures, organizing documentation, validating information before submission, protecting PHI and sensitive data, and demonstrating safeguards. This conversation is especially relevant for health system executives, compliance leaders, pharmacy leaders, 340B program managers, and teams responsible for operational oversight. Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, brings a clear and structured perspective to a complex process, helping organizations approach audit readiness with greater confidence, clarity, and control. Visit Virtue 340B’s episode landing page, https://virtue340b.com/content-hub/katys-340b-compass/, to watch this episode and explore other platform options. 1 0 Ep 23 - HRSA Audit Readiness: Clear 340B Oversight Steps ](https://www.youtube.com/watch?v=4_X3TsTSzSI) Ep 23 - HRSA Audit Readiness: Clear 340B Oversight Steps Katy's 340B Compass September 19, 2026 4:43 pm [ ![340B growth is often discussed as though rising program spending automatically reflects misuse, abuse, or a departure from the program’s intent. But that framing misses important context. Because 340B spending is measured in dollars, any meaningful discussion of growth must also account for the broader drug-pricing environment, patient acuity, and healthcare delivery pressures. In this episode of Katy’s 340B Compass, Katy Lees examines why price, total spending, utilization, and patient complexity should not be treated as the same measure. She discusses the role of rising drug acquisition costs, Medicare Case Mix Index trends, and other factors that shape how 340B growth should be interpreted. This episode is especially relevant for health system executives, compliance leaders, CFOs, pharmacy leaders, and governance teams seeking a more complete view of 340B oversight and policy discussions. Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, brings a calm, structured perspective to a complex issue. She focuses on helping healthcare leaders separate assumptions from evidence and understand what the data does—and does not—show. Visit Virtue 340B’s episode landing page https://virtue340b.com/content-hub/katys-340b-compass/ to explore other platform options.](https://virtue340b.com/wp-content/plugins/youtube-feed-pro/img/placeholder.png) 340B growth is often discussed as though rising program spending automatically reflects misuse, abuse, or a departure from the program’s intent. But that framing misses important context. Because 340B spending is measured in dollars, any meaningful discussion of growth must also account for the broader drug-pricing environment, patient acuity, and healthcare delivery pressures. In this episode of Katy’s 340B Compass, Katy Lees examines why price, total spending, utilization, and patient complexity should not be treated as the same measure. She discusses the role of rising drug acquisition costs, Medicare Case Mix Index trends, and other factors that shape how 340B growth should be interpreted. This episode is especially relevant for health system executives, compliance leaders, CFOs, pharmacy leaders, and governance teams seeking a more complete view of 340B oversight and policy discussions. Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, brings a calm, structured perspective to a complex issue. She focuses on helping healthcare leaders separate assumptions from evidence and understand what the data does—and does not—show. Visit Virtue 340B’s episode landing page https://virtue340b.com/content-hub/katys-340b-compass/ to explore other platform options. 2 0 Ep 22 - 340B Growth in Context: What the Data Really Shows ](https://www.youtube.com/watch?v=KcjPoJUMJpM) Ep 22 - 340B Growth in Context: What the Data Really Shows Katy's 340B Compass August 25, 2026 12:19 am [ ![In today’s 340B environment, organizations cannot control every external pressure affecting the program. But they can control how clearly they understand, document, and oversee their own operations. This episode of Katy’s 340B Compass explores how visibility, defensibility, and accountability help leaders strengthen control without relying on reactive compliance habits. Katy discusses key oversight areas that often shape organizational risk exposure, including patient definition, prescription eligibility, offsite department methodology, Medicaid alignment, duplicate discount prevention, and recertification. This episode is especially relevant for health system executives, compliance leaders, CFOs, pharmacy leaders, and 340B operations teams responsible for maintaining practical oversight. Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, translates complex program expectations into clear governance and operational considerations that leaders can use to support more defensible decision-making. Visit Virtue 340B’s episode landing page https://virtue340b.com/content-hub/katys-340b-compass/ to watch this episode and explore other platform options.](https://virtue340b.com/wp-content/plugins/youtube-feed-pro/img/placeholder.png) In today’s 340B environment, organizations cannot control every external pressure affecting the program. But they can control how clearly they understand, document, and oversee their own operations. This episode of Katy’s 340B Compass explores how visibility, defensibility, and accountability help leaders strengthen control without relying on reactive compliance habits. Katy discusses key oversight areas that often shape organizational risk exposure, including patient definition, prescription eligibility, offsite department methodology, Medicaid alignment, duplicate discount prevention, and recertification. This episode is especially relevant for health system executives, compliance leaders, CFOs, pharmacy leaders, and 340B operations teams responsible for maintaining practical oversight. Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, translates complex program expectations into clear governance and operational considerations that leaders can use to support more defensible decision-making. Visit Virtue 340B’s episode landing page https://virtue340b.com/content-hub/katys-340b-compass/ to watch this episode and explore other platform options. 1 0 Ep 21 - 340B Program Oversight: Clarity, Control, and Risk Visibility ](https://www.youtube.com/watch?v=NRkhDHN_5W0) Ep 21 - 340B Program Oversight: Clarity, Control, and Risk Visibility Katy's 340B Compass August 3, 2026 7:57 pm [ ![Proposed changes to 340B reimbursement and newly released legislative frameworks are raising important questions for covered entities, safety-net hospitals, and health system leaders. In this episode of Katy’s 340B Compass, Katy Lees examines the proposed CMS OPPS reimbursement change from ASP plus 6% to ASP minus 33.4%, and why organizations should evaluate the potential impact now. This episode also compares two 340B legislative approaches: the SECURE 340B Act and the Integrity/Affordability draft. Katy breaks down how each framework approaches discounts versus rebates, contract pharmacy access, patient definition, child-site requirements, transparency, patient affordability, payer and PBM conduct, and vendor compensation. The discussion is especially relevant for executives, CFOs, compliance leaders, pharmacy leaders, and teams responsible for 340B oversight and advocacy. Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, brings a clear and structured perspective to complex policy developments, helping organizations understand what these proposals may mean for risk visibility, operational planning, and defensible decision-making. Visit Virtue 340B’s episode landing page https://virtue340b.com/content-hub/katys-340b-compass/ to watch this episode and explore other platform options.](https://virtue340b.com/wp-content/plugins/youtube-feed-pro/img/placeholder.png) Proposed changes to 340B reimbursement and newly released legislative frameworks are raising important questions for covered entities, safety-net hospitals, and health system leaders. In this episode of Katy’s 340B Compass, Katy Lees examines the proposed CMS OPPS reimbursement change from ASP plus 6% to ASP minus 33.4%, and why organizations should evaluate the potential impact now. This episode also compares two 340B legislative approaches: the SECURE 340B Act and the Integrity/Affordability draft. Katy breaks down how each framework approaches discounts versus rebates, contract pharmacy access, patient definition, child-site requirements, transparency, patient affordability, payer and PBM conduct, and vendor compensation. The discussion is especially relevant for executives, CFOs, compliance leaders, pharmacy leaders, and teams responsible for 340B oversight and advocacy. Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, brings a clear and structured perspective to complex policy developments, helping organizations understand what these proposals may mean for risk visibility, operational planning, and defensible decision-making. Visit Virtue 340B’s episode landing page https://virtue340b.com/content-hub/katys-340b-compass/ to watch this episode and explore other platform options. 1 0 Ep 20 - 340B at a Crossroads: OPPS Cuts and Reform Bills ](https://www.youtube.com/watch?v=qUOF8X3R_ps) Ep 20 - 340B at a Crossroads: OPPS Cuts and Reform Bills Katy's 340B Compass July 13, 2026 1:15 am [ ![In today’s 340B environment, conversations about manufacturer-requested data often turn on a simple assumption: that the requested data is the same information covered entities already send to commercial insurers, Medicare, or Medicaid. But 340B operations are not always that simple. In many programs, payer claims are submitted before a 340B determination has been made, which means the claim sent for adjudication may not identify the dispense as 340B. In this episode of Katy’s 340B Compass, Katy Lees breaks down why timing, claim adjudication, accumulation, replenishment, reversals, eligibility logic, and third-party administrator processes all matter when evaluating 340B data-sharing requests. This discussion is especially relevant for health system executives, compliance leaders, pharmacy leaders, and 340B teams working through data strategy, risk exposure, and operational decision-making. Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, brings a practical and balanced perspective to a complex issue. Rather than taking a position on whether manufacturer data-sharing requirements are appropriate, she focuses on helping covered entities understand the operational facts, evaluate risks clearly, and make decisions grounded in their own systems, contracts, patient impact, and compliance considerations. Visit Virtue 340B’s episode landing page at https://virtue340b.com/content-hub__trashed/katys-340b-compass/ to watch this episode and explore other available viewing and listening options.](https://virtue340b.com/wp-content/plugins/youtube-feed-pro/img/placeholder.png) In today’s 340B environment, conversations about manufacturer-requested data often turn on a simple assumption: that the requested data is the same information covered entities already send to commercial insurers, Medicare, or Medicaid. But 340B operations are not always that simple. In many programs, payer claims are submitted before a 340B determination has been made, which means the claim sent for adjudication may not identify the dispense as 340B. In this episode of Katy’s 340B Compass, Katy Lees breaks down why timing, claim adjudication, accumulation, replenishment, reversals, eligibility logic, and third-party administrator processes all matter when evaluating 340B data-sharing requests. This discussion is especially relevant for health system executives, compliance leaders, pharmacy leaders, and 340B teams working through data strategy, risk exposure, and operational decision-making. Katy Lees, Principal 340B Compliance Advisor at Virtue 340B, brings a practical and balanced perspective to a complex issue. Rather than taking a position on whether manufacturer data-sharing requirements are appropriate, she focuses on helping covered entities understand the operational facts, evaluate risks clearly, and make decisions grounded in their own systems, contracts, patient impact, and compliance considerations. Visit Virtue 340B’s episode landing page at https://virtue340b.com/content-hub__trashed/katys-340b-compass/ to watch this episode and explore other available viewing and listening options. 0 0 Ep 19 - 340B Data Sharing: Why Timing and Context Matter ](https://www.youtube.com/watch?v=tEeYnJ_-Voo) Ep 19 - 340B Data Sharing: Why Timing and Context Matter Katy's 340B Compass June 15, 2026 4:13 pm Load More... [ Subscribe ](https://www.youtube.com/channel/UCvfWkvgB8yS1JELGKCvnkqw/) ## Take the Compass With You Prefer to listen on the go? Katy's 340B Compass is available wherever you get your podcasts. Subscribe on Spotify or your favorite platform and stay current with timely discussions that make compliance more approachable. [ Listen on Spotify ](https://open.spotify.com/show/4gweTuD4iZwt4JuGNvr4iu?si=e2ec50fbdc864df4)